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FDA posts a new CDER manual of policies and procedures (MAPP) 5021.5, Assessment of Facility-Based Deficiency Major-to-Minor Recla...[ Price : $8.95]
FDA approves an Ironwood Pharmaceuticals supplemental NDA for Linzess (linaclotide) Linzess (linaclotide) to treat functional cons...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension on voluntarily submitted medical device regulat...[ Price : $8.95]
BearCare recalls it rechargeable Walnut Wearable Smart Thermometer due to reports about skin burns and irritation.[ Price : $8.95]
FDA accepts for review a Phathom Pharmaceuticals NDA resubmission for vonoprazan, a potassium-competitive acid blocker to treat er...[ Price : $8.95]
FDA clears a GE HealthCare 510(k) for the Sonic DL a deep learning-based technology designed to dramatically accelerate image acq...[ Price : $8.95]
FDA approves a Ferring Pharmaceuticals BLA supplement for intravesical gene therapy Adstiladrin and the companys plan to scale up ...[ Price : $8.95]
Former FDA commissioner Scott Gottlieb and his former chief of staff Lauren Silvis say FDA needs new policies geared toward integr...